MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 740 VR-T DX; ICD

Model Number	372419
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device explanted due to reaching eos on (b)(6) 2021.No adverse patient events reported.Should additional information become available, it will be added to this file.On 17-mar-2021 device received.
Additional Manufacturer Narrative
The icd was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were reinvestigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt, the icd was interrogated, revealing the eos battery status, detected on march 05, 2020.The device was implanted for 94 months and 150 charging cycles were recorded in the devices memory.The amount of charge taken from the battery was verified and found to be normal and as expected.The eos status was removed with a technical programmer and the ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device detected the fibrillation signal as specified.However, the shock therapy was not available as a result of the battery depletion.In conclusion, the battery status eos was anticipated.There was no indication of an icd malfunction.

• Brand Name: LUMAX 740 VR-T DX
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11529198
• Report Number: 1028232-2021-01289
• Device Sequence Number: 3997442
• Product Code: LWS
• UDI-Device Identifier: 04035479116057
• UDI-Public: 04035479116057
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 372419
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 41 YR